MAUDE Adverse Event Report: TOSOH CORPORATION AIA-900

Model Number AIA-900

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Readings (2459)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/02/2020

Event Type  malfunction  

Manufacturer Narrative

Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.A 13-month lot review for similar complaints was performed for test cup lot j7141a3 and for calibrator lot jy33137.There were no complaints found during the searched period.A 13-month complaint history review and service history review through aware date of event for similar complaints was performed for serial number (b)(4).There were no other similar complaints found during the searched period.The st aia-pack prl analyte application manual states the following: calibration and calibration curve.The calibration curve for the st aia-pack prl is stable for up to 90 days.Calibration stability is monitored by quality control performance and is dependent upon proper reagent handling and aia system maintenance according to the manufacturer's instructions.Recalibration may be necessary more frequently if controls are out of the established range for this assay or if certain service procedures are performed (e.G.Temperature adjustment, sampling mechanism changes, or detector lamp adjustment or change).For further information regarding instrument operation, consult the aia system operator's manual.Evaluation of results.Quality control.In order to monitor and evaluate the precision of the analytical performance, it is recommended that commercially available control samples be assayed daily.The minimum recommendations for the frequency of running internal control material are: after calibration, two levels of controls are run in order to accept the calibration curve.The two levels of controls are also repeated after calibration when certain service procedures are performed (e.G.Temperature adjustment, sampling mechanism changes, maintenance of the wash probe or detector lamp adjustment or change).After daily maintenance, at least two levels of the control should be run in order to verify the overall performance of the tosoh aia system analyzers.If one or more control sample value(s) is out of the acceptable range, it will be necessary to investigate the validity of the calibration curve before reporting patient results.Limitations of the procedure.For diagnostic purposes, the results obtained from this assay should be used in conjunction with other data (e.G., symptoms, results of other tests, clinical impressions, therapy, etc.).Using st aia-pack prl, the highest concentration of prolactin measurable without dilution is 200 ng/ml, and the lowest measurable concentration is 1.0 ng/ml (assay sensitivity).Although the approximate value of the highest calibrator is 100 ng/ml, the exact concentration may be slightly different.The assay specification, assay range high, should be defined as the upper limit of the assay range, 200 ng/ml.Certain medications may interfere with assay performance.Specimens from patients taking medicines and/or medical treatment may show erroneous results.All results should be interpreted with respect to the clinical picture of the patient.The most probable cause of the reported event is unknown.

Event Description

A customer reported getting out of range high quality control (qc) result for prolactin (prl) on the aia-900 instrument.The customer is running prl test cup lot j7141a3 and calibrator lot jy33137.Customer stated calibration was completed several times; results will come into range then be out the next day.Technical support specialist (tss) sent mac controls and another lot of calibration to the customer.After recalibration, customer reported all results are within acceptable range.There was no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

• Brand Name: AIA-900
• Type of Device: AIA-900
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, 10586 23; JA 1058623
• Manufacturer (Section G): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, 10586 23; JA 1058623
• Manufacturer Contact: bernadette oconnell ; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586-23 ; JA 1058623
• MDR Report Key: 9908379
• MDR Text Key: 261057140
• Report Number: 8031673-2020-00088
• Device Sequence Number: 1
• Product Code: KHO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIA-900
• Device Catalogue Number: 022930111
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/02/2020
• Initial Date FDA Received: 03/31/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1